Fibroblast Injection for Amputation Healing

Overseen By Ruizhi Wang, MPhil

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: Immunosuppressants, Topical steroids, Sulfonamides, others

Disqualifiers: Autoimmune conditions, Metastatic cancer, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on chronic immunosuppressive therapies and certain other medications. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Fibroblast Injection for Amputation Healing?

Research shows that using autologous fibroblasts (cells from a person's own skin) can help improve wound healing in various conditions, such as diabetic ulcers and skin scars, by enhancing skin thickness, elasticity, and healing rates. This suggests that fibroblast injections might also aid in healing after amputations. ^{1 2 3 4 5}

Is fibroblast injection safe for humans?

Research shows that fibroblast injections, used for various skin conditions, have been generally safe in humans. Studies involving hundreds of patients reported no adverse reactions or tumor formation, indicating a good safety profile. ^{1 4 5 6 7}

How is the treatment of autologous skin fibroblasts unique for amputation healing?

The treatment using autologous skin fibroblasts is unique because it involves injecting a patient's own skin cells to promote healing, which is different from traditional methods that might not use living cells. This approach has shown promise in improving skin elasticity and healing in other conditions, making it a novel option for amputation healing. ^{1 2 3 4 6}

Research Team

Luis Garza, MD, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults aged 18-65 with below-knee amputations who use a prosthetic. Women must not be pregnant, breastfeeding, or planning to become pregnant and agree to contraception. Excluded are those with deep skin erosions, certain medical conditions (like autoimmune diseases), allergies to study materials, active infections, recent neuromas, or on immunosuppressives.

Inclusion Criteria

I have had an amputation below the knee.

I have been using a prosthetic for at least 3 months or had one integrated into my bone for 1 month.

I am either male or female.

Exclusion Criteria

I have dead tissue on my amputation site or slow blood return in the skin.

I am not on long-term immunosuppressive treatments, including oral or topical steroids.

You have taken any experimental medication within the last month before joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous volar fibroblast injections at the stump site to assess safety and efficacy in increasing epidermal thickness and skin firmness

1 month

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of skin breakdown and quality of life

12 months

Regular follow-up visits

Treatment Details

Interventions

• Autologous Skin Fibroblasts
• Placebo

Trial Overview The trial tests autologous volar fibroblast injections versus placebo in thickening the stump's skin layer for amputees. Participants will receive either their own cultured skin cells or a placebo injected into the stump site at Johns Hopkins.

Participant Groups

Group I: Autologous skin fibroblasts Experimental Treatment 1 Intervention

For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts.

Group II: Control Placebo Group 1 Intervention

For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Autologous fibroblast transplantation is a safe and effective method for improving atrophic scars caused by cutaneous leishmaniasis, with no observed side effects in the study.

The treatment led to significant improvements in epidermal thickness, melanin levels, and skin elasticity after two injections, although dermal thickness did not show improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fibroblast transplantation in the healing of cutaneous leishmaniasis scar: A case report. Faghihi, F., Larijani, G., Mohebbi, L., et al.[2023]

In a study using a porcine model of delayed wound healing, both autologous fibroblasts and keratinocytes significantly improved the re-epithelialization rates of diabetic skin wounds, achieving rates of 86.75% and 91.3%, respectively, compared to only 56.8% in saline-treated wounds.

This research suggests that while fibroblast suspensions have shown limited effectiveness in non-diabetic wounds, they can be beneficial for enhancing healing in diabetic wounds, indicating a potential new treatment strategy for diabetic skin injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell suspensions of autologous keratinocytes or autologous fibroblasts accelerate the healing of full thickness skin wounds in a diabetic porcine wound healing model. Velander, P., Theopold, C., Bleiziffer, O., et al.[2009]

In a study involving five diabetic patients with long-standing skin ulcers, autologous skin cell implants (fibroblasts and keratinocytes) led to complete healing in 83.3% of ulcers within 21 to 120 days, demonstrating significant efficacy for difficult-to-heal diabetic ulcers.

The treatment was safe, with no adverse reactions reported, and it is a minimally invasive procedure that can be performed in an outpatient setting, making it a promising option for patients unresponsive to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue therapy with autologous dermal and epidermal culture cells for diabetic foot ulcers. Marcelo, D., Beatriz, PM., Jussara, R., et al.[2018]

Cultured autologous fibroblasts (Isolagen) have been effectively used in 1,450 patients to treat various skin issues, showing a high patient satisfaction rate of 92% regarding the correction of skin conditions after treatment.

Long-term follow-up (36 to 48 months) indicated that 70% of patients experienced continued improvement beyond the initial results, suggesting that this injectable system not only provides immediate correction but also promotes ongoing skin repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous cultured fibroblasts: a protein repair system. Boss, WK., Usal, H., Fodor, PB., et al.[2022]

A patient with diabetes and severe wound complications healed a large (103.49 cm²) wound using a two-stage autologous skin substitute technique, demonstrating the efficacy of this novel approach.

The wound completely healed within 60 days after the first application of cultured fibroblasts, and after 16 months, there was no recurrence, allowing the patient to walk independently, highlighting the potential of this technique for improving wound healing in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using hyaluronic acid derivatives and cultured autologous fibroblasts and keratinocytes in a lower limb wound in a patient with diabetes: a case report. Dalla Paola, L., Cogo, A., Deanesi, W., et al.[2004]

In a study involving 20 patients aged 37-61, autologous dermal fibroblasts were successfully used for facial soft tissue augmentation, leading to significant and sustained clinical improvements in facial rhytides and atrophic scars.

The fibroblasts used were functionally active, producing large amounts of type I collagen, and showed no oncogenic properties or tumor formation in animal models, indicating a safe profile for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of injectable autologous human fibroblasts. Keller, G., Sebastian, J., Lacombe, U., et al.[2019]

The study involved 19 patients who received autologous cultured skin fibroblast injections to treat depressed facial skin defects, showing significant improvement in skin appearance after treatment.

The procedure was found to be safe, with only minor adverse events reported, and no serious complications or excessive cell proliferation, indicating that this method could be a reliable option for facial skin rejuvenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary clinical observations on autologous cultured skin fibroblasts transplantation to treat the facial soft tissue deficiencies]. Zeng, W., Wei, ZR., Liu, D., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of fibroblast transplantation in the healing of cutaneous leishmaniasis scar: A case report. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cell suspensions of autologous keratinocytes or autologous fibroblasts accelerate the healing of full thickness skin wounds in a diabetic porcine wound healing model. [2009]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Tissue therapy with autologous dermal and epidermal culture cells for diabetic foot ulcers. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Autologous cultured fibroblasts: a protein repair system. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Using hyaluronic acid derivatives and cultured autologous fibroblasts and keratinocytes in a lower limb wound in a patient with diabetes: a case report. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of injectable autologous human fibroblasts. [2019]

7. China pubmed.ncbi.nlm.nih.gov

[Preliminary clinical observations on autologous cultured skin fibroblasts transplantation to treat the facial soft tissue deficiencies]. [2013]